An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212015
Company: TORRENT

Products on ANDA 212015

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	AB	No	No
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212015

ERYTHROMYCIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	219691	ABON PHARMS LLC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	061621	CARNEGIE
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	219691	ABON PHARMS LLC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	061621	CARNEGIE
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

Top